Handle for medical device deployment

ABSTRACT

A delivery system for endoluminal delivery of an expandable device comprising a catheter having a proximal end and an opposite distal end configured to support an expandable device, a primary sheath having a delivery position in which the primary sheath constrains the expandable device toward a collapsed configuration suitable for endoluminal delivery, and a handle having an actuator for axially displacing the primary sheath from the delivery position, wherein the handle includes a knob for operating one or more functions of the handle which is initially hidden to prevent use by a user and then revealed as a result of displacement of the primary sheath from delivery position so as to allow subsequent actuation of the knob by the user.

BACKGROUND

1. Field

The present disclosure relates to handles for medical device deploymentsystems and, more particularly, to handles configured for use inmulti-stage deployment systems for expandable medical devices.

2. Discussion

Handles for catheter-based deployment systems for endoluminal deliveryof expandable devices are well-known in the art. It remains desirable toprovide improved handles that can accommodate multi-stage endoluminaldelivery and deployment of expandable medical devices, while improvingor at least maintaining ease of operation to the clinician.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the present disclosure and are incorporated in andconstitute a part of this specification, illustrate embodiments of thepresent disclosure and together with the description serve to explainthe principles of the present disclosure.

FIGS. 1-5 are cutaway perspective views of a deployment handle for amedical device delivery system, shown in successive stages of use; and

FIGS. 2A and 3A are enlarged views of FIGS. 2 and 3, respectively.

DETAILED DESCRIPTION

A handle mechanism is disclosed herein for use in connection withdelivery systems for endoluminal delivery and deployment of medicaldevices, such as vascular endoprosthetic implants. A delivery system inaccordance with the present disclosure can include a first actuator forselectively actuating a first tubular member and a second actuator forselectively actuating a second tubular member, wherein the secondactuator is initially hidden and subsequently presented for use inresponse to operation of the first actuator.

Referring to FIGS. 1-5, for example, a medical device delivery system isgenerally indicated at 100. The delivery system 100 includes a catheter(not shown) having a proximal end and an opposite distal end. The distalend of the catheter is configured for supporting at least oneexpandable, endoluminally deliverable medical device (not shown).Examples of endoluminally deliverable medical devices include stents,grafts, replacement heart valves, and the like, or any combinationthereof.

The delivery system can include one or more tubular members forreleasably constraining the medical device for endoluminal delivery anddeployment. The delivery system 100 can, for example, include anelongated first tubular member 200 having a generally cylindricallyshaped side wall defining a longitudinally extending lumen (not shown).The first tubular member 200 can have a delivery configuration, in whichthe medical device is placed within the lumen and constrained by theside wall toward a constrained state suitable for endoluminal deliveryof the medical device. The delivery system 100 can also include anelongated second tubular member 300 having a generally cylindricallyshaped side wall defining a longitudinally extending lumen (not shown).In the delivery configuration, the second tubular member 300 can bedisposed between the first tubular member 200 and the medical device tolimit expansion of medical device following removal or displacement ofthe first tubular member 200 from the delivery configuration. Morespecifically, the second tubular member 300 can limit expansion of themedical device toward an intermediate state that is larger than theconstrained state and yet still smaller than a fully-deployed state, soas to allow axial and rotational positioning of the medical device atthe treatment site prior to committing to a full deployment of themedical device. Examples of tubular members include catheters, sheaths,and introducers, or any elongate, tubular member used for supporting andendoluminally delivering a medical device. The tubular members can beconstructed using any suitable material or combination of materials,such as polymers, polymer films, and braided wire structures, and anysuitable methods known to those having ordinary skill in the art, suchas injection molding, extrusion, flow-formed layered wraps, or anycombination thereof.

The delivery system includes a handle having actuators and interfaces,such as knobs, operable to facilitate displacement, removal or actuationof the first and second tubular members from their respective deliveryconfigurations. Such a handle is disclosed in FIGS. 1-5 and generallyindicated at 400. The handle 400 includes an outer housing 402. Thehandle 400 is disposed along and coupled to the proximal end of thecatheter. The handle 400 includes a first actuator mechanism 410 and afirst knob 420 for manual operation of the first actuator mechanism 410.The first actuator mechanism 410 includes a follower 412 that is axiallydisplaceable as indicated by the arrow “A” in FIG. 1 in response tocorresponding operation of the first knob 420. The follower 412 is, inturn, coupled to the first tubular member 200 to cause axialdisplacement of the first tubular member with the follower 412 duringoperation of the first knob 420. The first tubular member 200 is shownin FIG. 1 in the delivery configuration. In this configuration, thefollower 412 is positioned at a distal portion 404 of the handle 400.Operation of the first knob 420 causes displacement of the first tubularmember 200 with the follower 412 from the delivery configuration, asshown in FIG. 1, toward the proximal portion 408 of the handle 400, asshown in FIGS. 2-4.

Still referring to FIGS. 1-4, the handle 400 includes a second actuatormechanism 500 and a second knob 520 for manual operation of the secondactuator mechanism 500. As shown in FIG. 1, with the first tubularmember 200 in the delivery configuration, the second knob 520 ispositioned and hidden at a proximal portion 408 of the handle 400. Anarm 522 extends from the second knob 520 toward the distal portion 404of the handle 400 for engaging the follower 412 during operation of thefirst actuator mechanism 410. As shown, in the delivery configuration,an end of the arm 522 can be spaced apart from the follower 412 to allowan initial displacement of the first tubular member 200 without causingcorresponding displacement of the second knob 520 from the housing 402.The second knob 520 and arm 522 are supported by and slidably coupled tothe housing 402 to allow displacement of the second knob 520 from thehandle housing 402 during movement of the follower 412 with the firsttubular member 200 between the positions shown in FIG. 1 and FIG. 3.

Optionally, a receiver 530 can be provided to support and locate the endof the arm 522 relative to the handle 400. A distal end 532 of thereceiver 530 is configured to engage the follower 412 instead of the endof the arm 522, as previously discussed. The opposite proximal end 534of the receiver 530 is defined by a pair of legs 536. The legs 536 arespaced apart to receive the end of the arm 522 therebetween.

The actuator mechanisms of the handle can include a variety ofmechanisms for moving or actuating the tubular members in response toactuation of respective knobs of the handle. The first actuatormechanism 410 of the handle 400 shown in the figures, for example,includes a helically threaded positioner mechanism 600 for displacingthe first tubular member 200 along an axis 610 in response to rotationof the first knob 420 about the axis 610.

The positioner mechanism 600 includes a helical slot or guide 620 formedalong an inner surface 632 of a tubular wall 630 that extends from thefirst knob 420. The wall 630 and, therefore, the helical guide 620rotate with the first knob 420. The follower 412 is disposed within alumen defined by the wall 630, is engaged with the helical guide 620 andis rotatably constrained with respect to the axis 610, so that rotationof the helical guide 620 with the first knob 420 causes axialdisplacement of the follower 412 and the first tubular member 200therewith, relative to the catheter and the second tubular member 300.Thus, rotation of the first knob 420 causes or allows progressiveexpansion of the medical device from the constrained state as the firsttubular member 200 is retracted relative to the catheter from thedelivery configuration of FIG. 1 to the various stages of displacementshown in FIGS. 2-3.

Referring to FIG. 3A, eventual engagement between the proximal end 534of the receiver 530 and a locating surface 406 in the handle 400provides a positive stop to prevent further axial displacement of thefollower 412, first tubular member 200 and, in turn, further rotation ofthe first knob 420.

As earlier discussed, expansion of the medical device from theconstrained state following removal of the first tubular member 200 islimited to the intermediate state by the second tubular member 300.Maintaining the medical device at the intermediate state allows axial orrotational positioning of the medical device at the treatment site priorto committing to full deployment.

The second tubular member 300 can also be axially retracted like thefirst tubular member. Alternatively, the second tubular member 300 canbe formed from a film sleeve held together by an elongated member (notshown), such as a deployment wire or fiber. An example of the latterarrangement is disclosed in U.S. Pat. No. 6,352,561 to Leopold et al.,the content of which is incorporated herein by reference in itsentirety. In either case, the second actuating mechanism 500 may beprovided as a coupling between the second knob 520 and the secondtubular member 300 and/or the elongated member, so that removing thesecond knob 520 from the handle 400 causes removal and/or opening orotherwise actuation of the second tubular member 300.

In operation, the first knob 420 is rotated to actuate the threadedpositioner mechanism 600 and cause displacement of the first tubularmember 200 from the position in FIG. 1 toward the position in FIG. 3. Asearlier discussed, the follower 412 is initially spaced apart from theend of the arm 522. Thus, the second knob 520 remains undisturbed andhidden inside the outer housing 402 near the proximal portion 408 of thehandle 400 during initial actuation of the first knob 420 to prevent useof the second knob 520.

Displacement of the first tubular member 200 relative to the medicaldevice allows the medical device to expand from the constrained statetoward the second tubular member 300, which limits expansion of themedical device to the intermediate state. In this state, the clinicianmay choose to make final axial and/or rotational adjustments of theposition of the medical device prior to full deployment of the medicaldevice. Once the medical device is placed at a desired position at thetreatment site, the clinician can continue to operate the first knob420.

Eventually, as shown in FIG. 2, the follower 412 contacts the end of thearm 522 so that continued operation of the first knob 420 and movementof the first tubular member 200 translates into displacement of thesecond knob 520 from the outer housing 402, as shown in FIG. 3, whereinthe second knob 520 is presented for use by the clinician. The secondknob 520 and arm 522 can be removed and separated from the handle 400,as shown in FIGS. 4 and 5, to cause displacement and/or otherwiseopening of the second tubular member 300 to allow expansion of themedical device toward engagement with surrounding vessel tissue.

The second knob 520 can include a slot 524 to accommodate use of aguidewire (not shown), which allows the second knob 520 to besubstantially coaxial or otherwise near the axis 610.

After full deployment of the medical device, the handle 400 can beseparated from the first tubular member 200 to allow the first tubularmember 200 to be used as an introducer sheath for other medical devicesor related surgical implements.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present disclosurewithout departing from the spirit or scope of the present disclosure.Thus, it is intended that the present present disclosure cover themodifications and variations of this present disclosure provided theycome within the scope of the appended claims and their equivalents.

What is claimed is:
 1. A delivery system for endoluminal delivery of anexpandable device, said delivery system comprising a catheter having aproximal end and an opposite distal end, the distal end configured tosupport an expandable device; a primary sheath having a deliveryposition in which the primary sheath constrains the expandable devicetoward a collapsed configuration suitable for endoluminal delivery; ahandle having an actuator for axially displacing the primary sheath fromthe delivery position, the handle having a knob for operating one ormore functions of the handle, wherein the knob is initially hidden toprevent use by a user and then revealed as a result of displacement ofthe primary sheath from delivery position so as to allow subsequentactuation of the knob by the user.
 2. The delivery system as set forthin claim 1 including a secondary sheath having a delivery position inwhich the secondary sheath limits expansion of the expandable device toan intermediate configuration larger than the constrained configurationand smaller than a fully deployed configuration.
 3. The delivery systemas set forth in claim 2, wherein the one or more functions of the handleincludes deployment of the secondary sheath to allow deployment of theexpandable device from the intermediate configuration.
 4. The deliverysystem as set forth in claim 3, wherein the arm is coupled to thesecondary sheath, wherein removal of the knob from the handle causesremoval of the secondary sheath and, in turn, deployment of theexpandable device toward the fully deployed configuration.
 5. Thedelivery system as set forth in claim 1, wherein the displacement of theprimary sheath is axial.
 6. The delivery system as set forth in claim 1,wherein the knob includes a longitudinally extending arm for engagingthe primary sheath, whereby the knob is displaced from an initiallyhidden position and revealed in response to the axial movement of theprimary sheath from the delivery position.
 7. The delivery system as setforth in claim 6 including a follower fixedly secured to the primarysheath for movement therewith.
 8. The delivery system as set forth inclaim 7 including a receiver slidably coupled to the handle, and havinga first end for engaging the follower as the primary sheath moves fromthe delivery position and an opposite second end for engaging an end ofthe arm.
 9. The delivery system as set forth in claim 8 wherein thereceiver includes a pair of legs extending outwardly from the second endwhich are spaced apart to define a tapered recess that receives the endof the arm therein.
 10. The delivery system as set forth in claim 7,wherein the sheath is displaceable by actuation of a positionermechanism, the positioner mechanism having a tubular wall having alongitudinal axis and an inner surface defining a lumen extending alongthe longitudinal axis, the lumen capable of receiving the sheath andfollower therethrough.
 11. The delivery system as set forth in claim 10,wherein the inner surface includes a helically extending slot forengaging the follower, wherein rotation of the tubular wall aboutlongitudinal axis causes axial displacement of the sheath and followeralong the lumen.
 12. The delivery system as set forth in claim 7,wherein the follower and receiver are spaced apart when the primarysheath is in the delivery position, so that the knob is revealed afteran initial delay following at least a partial deployment of theexpandable device.
 13. A delivery system for endoluminal delivery of anexpandable device, said delivery system comprising a catheter having aproximal end and an opposite distal end, the distal end configured tosupport an expandable device; a primary sheath having a deliveryposition in which the primary sheath constrains the expandable devicetoward a collapsed configuration suitable for endoluminal delivery; ahandle having an actuator for axially displacing the primary sheath fromthe delivery position, the handle having a knob for operating one ormore functions of the handle, wherein the knob is initially hidden toprevent use by a user and then revealed as a result of displacement ofthe primary sheath so as to allow subsequent actuation of the knob bythe user, wherein the knob is revealed after an initial delay followingdisplacement of the primary sheath from the delivery position.